) presented final data from the first phase I study (n=50) on
ONT-380 (also known as ARRY-380). The final results from this
study were presented at the American Association for Cancer
Research Special Conference on Advances in Breast Cancer
Research. ONT-380 is an orally active, reversible and selective
small-molecule HER2 (human epidermal growth factor receptor 2)
43 out of the 50 patients were suffering from HER2+ metastatic
breast cancer. The safety profile of ONT-380 was found to be
acceptable level with treatment-related adverse events being
primarily restricted to Grade 1. Only one patient was observed to
have suffered treatment-related diarrhea of Grade 2 level and one
patient experienced Grade 3 rash.
Additionally, no Grade 4 or cardiac events related to the
treatment were observed. A dosage of 600 mg twice daily was
ascertained as the maximum tolerated dose in this study. A
clinical benefit rate of 27% was observed in 22 HER2+ breast
cancer patients treated with ONT-380 (dosage >= 600 mg twice
We note that Oncothyreon has been working hard for developing
ONT-380. We also note that Oncothyreon has a collaboration
Array BioPharma, Inc.
) to develop and commercialize ONT-380.
As per the agreement, Oncothyreon will be responsible for the
development of ONT-380 in patients suffering from metastatic
breast cancer, including patients with brain metastases.
Array and Oncothyreon plan to jointly conduct a phase III
program on the candidate, supported by proof-of-concept studies.
Both Array and Oncothyreon will have the right to stop further
development and commercialization in lieu of royalty
While Array will be responsible for the worldwide
commercialization of the candidate, Oncothyreon will enjoy
co-promotion rights to the candidate in the U.S. However, the
companies will share the commercialization costs and profit
equally in the U.S. Oncothyreon is entitled to receive
double-digit royalty on net sales in ex-U.S. markets. Moreover,
the companies will share any proceeds from sublicense of the
marketing rights evenly.
Oncothyreon carries a Zacks Rank #4 (Sell). Currently,
companies which look attractive include
) with a Zacks Rank #1 (Strong Buy) and
) with a Zacks Rank #2 (Buy).
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